RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has announced the publication of groundbreaking results from its pivotal Phase 3 Launch-HTN trial in the Journal of the American Medical Association (JAMA). The study highlights the efficacy and safety of lorundrostat, a first-in-class aldosterone synthase inhibitor (ASI), in addressing uncontrolled and treatment-resistant hypertension, a condition linked to severe cardiovascular risks.
The Launch-HTN trial, the largest Phase 3 study to date for an ASI, involved 1,083 participants globally who had yet to achieve blood pressure control despite taking two to five antihypertensive medications. Results showed that lorundrostat administered at a 50 mg once-daily dose led to significant reductions in systolic blood pressure. By Week 6, participants experienced a 16.9 mmHg reduction in systolic BP, which further improved to 19.0 mmHg by Week 12. These reductions, adjusted for placebo, were clinically meaningful, with reductions of -9.1 mmHg and -11.7 mmHg respectively (both with p-values < 0.0001).
Lorundrostat demonstrated consistency in its efficacy across diverse groups, including variations in age, sex, race, baseline body mass index, and medication regimen. The drug also showed strong tolerability with most treatment-emergent adverse effects being mild, temporary, and reversible. Notably, serious side effects resulting in medication discontinuation or dose adjustment were rare.
“Hypertension remains the most prevalent and preventable driver of cardiovascular disease globally, yet a significant proportion of patients continue to struggle with inadequate blood pressure control. We believe lorundrostat has the potential to be a best-in-class treatment for patients with uncontrolled or treatment-resistant hypertension,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “We are pleased to have the results of Launch-HTN published in a medical journal as prestigious as JAMA. The consistency of results seen in the lorundrostat development program – which includes multiple trials across differentiated patient populations – supports its potential to have a broad role in future hypertension care.”
Dr. Manish Saxena, the trial’s lead investigator, described the findings as a promising leap forward. “Launch-HTN was the largest Phase 3 trial of an ASI in patients with uncontrolled or resistant hypertension, designed to reflect usual clinical practice. It demonstrated consistent blood pressure lowering efficacy and safety with the aldosterone synthase inhibitor, lorundrostat, across a diverse group of patients,” said Dr. Saxena, Deputy Clinical Co-Director of Queen Mary University of London’s William Harvey Heart Centre and Hypertension Specialist at Barts Health NHS Trust. “Dysregulated aldosterone, a key factor in driving hypertension in up to 30% of all hypertensive patients, is a consistent feature of treatment-resistant hypertension and related cardiovascular morbidities, such as heart failure and chronic kidney disease, making aldosterone synthase inhibition an attractive treatment target. Lorundrostat, a novel ASI therapy, is a promising development that could help address unmet clinical needs for patients who remain hypertensive despite multiple medications.”
Hypertension not only increases the risk of heart disease, heart attack, and stroke but also poses an extraordinary economic burden. Despite the availability of numerous antihypertensive medications, less than 50% of patients achieve their target blood pressure goals. Mineralys Therapeutics aims to address this unmet need with lorundrostat, a selective aldosterone synthase inhibitor designed to manage dysregulated aldosterone levels linked to the condition.
The publication of the Launch-HTN findings in JAMA represents a critical milestone for Mineralys in its efforts to improve hypertension care and advance lorundrostat toward clinical use alongside broader indications like chronic kidney disease and obstructive sleep apnea. This achievement reflects the company’s commitment to transforming standards for managing resistant hypertension and its associated risks.
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